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EMA reviews its first biosimilar monoclonal antibody Posted 27/04/2012

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012 the agency will be reviewing a new application for a biosimilar version of infliximab.

Infliximab is a monoclonal antibody, which works by binding to tumour necrosis factor-alpha (TNF-α). TNF-α is a chemical messenger (cytokine) and a key part of the autoimmune reaction. Infliximab therefore acts as an anti-inflammatory drug and is used to treat ankylosing spondylitis, Crohn’s disease, psoriatic arthritis and psoriasis, rheumatoid arthritis, ulcerative colitis.

The drug is a biosimilar of Johnson & Johnson’s blockbuster Remicade, which had sales of US$8 billion in 2010.

Although EMA has not identified the company behind the application, a likely candidate is South Korean biotechnology company Celltrion, which announced in February 2012 the successful completion of its clinical programme for its infliximab biosimilar [1].

Celltrion has a partnership with US-based generics major Hospira to develop and market eight biosimilars, including infliximab and cancer drug trastuzumab [1, 2].

Biosimilars for epoetins, filgrastim and somatropin have already been approved by EMA [3]; however, this is the first application for a biosimilar of a monoclonal antibody to be submitted to EMA.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Successful completion of biosimilar infliximab programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Successful-completion-of-biosimilar-infliximab-programme

2.  GaBI Online - Generics and Biosimilars Initiative. Hospira looks to biosimilars and increased use of generics for growth [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/News/Hospira-looks-to-biosimilars-and-increased-use-of-generics-for-growth

3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

Source: EMA

Comments (2)

Response to ‘How can it be called "Infliximab"…’ posted 25/09/2012 - by Lasia, GaBI Online Editorial Office

Dear Dr Voskhul, This information is according to what EMA announced. In view of your comment, we have updated the wording of the article. It is possible that the product will have a pre-fix for differentiation when it is approved by EMA. Please visit the following link for further information on Celltrion's infliximab: http://gabionline.net/Biosimilars/News/Successful-completion-of-biosimilar-infliximab-programme Best regards, Lasia, Publisher, GaBI Online

How can it be called "Infliximab" - should it not have an unique INN??? posted 30/04/2012 - by Dr Voskhul

How can Celltrion file a molecule called just "Infliximab" - did the EMA not require an unique INN for this?